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Elavil was a trade name for amitriptyline hydrochloride, a tricyclic antidepressant. FDA lists the original Elavil oral tablets as discontinued and determined that their withdrawal was not for safety or effectiveness reasons. Generic amitriptyline tablets remain marketed for relief of symptoms of depression.
read more about elavil ...The exact antidepressant mechanism of amitriptyline is unknown. It inhibits neuronal uptake of norepinephrine and serotonin, which prolongs activity of these neurotransmitters at nerve endings. Amitriptyline also has sedative and anticholinergic effects that contribute to its adverse-reaction profile.
Current amitriptyline tablet labeling is for relief of symptoms of depression. Safety and efficacy in pediatric patients have not been established. Dosing is individualized according to symptom severity, age, clinical response, adverse reactions, and whether treatment occurs in an outpatient or hospital setting.
Adult outpatients commonly start at 75 mg daily in divided doses and can increase to 150 mg daily. Another outpatient schedule starts with 50 mg to 100 mg at bedtime. Hospitalized patients can start at 100 mg daily and can require gradual increases, with a small number receiving up to 300 mg daily.
Amitriptyline carries a boxed warning for suicidal thoughts and behaviors in children, adolescents, and young adults taking antidepressants. Other serious concerns include cardiac arrhythmias, conduction changes, seizures, angle-closure glaucoma, urinary retention, low sodium, severe overdose toxicity, and additive central nervous system depression with alcohol. MAOI use with amitriptyline is contraindicated.
No. FDA lists the original Elavil tablets as discontinued, while generic amitriptyline tablets remain marketed.
FDA determined that the original Elavil tablets were not withdrawn for safety or effectiveness reasons.
Current tablet labeling is for relief of symptoms of depression.
Adult outpatients commonly start at 75 mg daily in divided doses.
Amitriptyline. https://www.ncbi.nlm.nih.gov/books/NBK537225/. Date Accessed September 29, 2026.
Amitriptyline: MedlinePlus Drug Information. https://medlineplus.gov/druginfo/meds/a682388.html. Date Accessed September 29, 2026.
Amitriptyline Hydrochloride Tablet, Film Coated. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26. Date Accessed September 29, 2026.
Depression Medicines. https://www.fda.gov/consumers/womens-health-topics/depression-medicines. Date Accessed September 29, 2026.
Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. https://www.federalregister.gov/d/2017-22892. Date Accessed September 29, 2026.